Acne Vulgaris
Conditions
Keywords
Efficacy, Safety, Acne vulgaris
Brief summary
Assessment of the efficacy and safety of CD5789 (trifarotene) 50μg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.
Detailed description
Clinical Trial for each subject is approximately 14 weeks and are randomized to one of the two treatments for 12 weeks. Subjects must be 9 years of age and older with acne vulgaris.
Interventions
DRUGCD5789 (trifarotene) 50μg/g cream
CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
DRUGPlacebo cream
Placebo cream applied once daily for 12 weeks
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is a male or female, 9 years of age or older, at Screening visit. * The Subject has moderate acne at Screening and Baseline. * The subject is a female of non childbearing potential * The subject is a female of childbearing potential with a negative pregnancy test and who is strictly abstinent or who agrees to use an effective and approved contraceptive method for the duration of the study and at least 1 month after the last study drug application.
Exclusion criteria
* The subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.). * The subject has any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part to the trial. * The subject has been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the subject is planning intense UV exposure during the study (i.e., occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.) * The subject is unwilling to refrain from use of prohibited medication during the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment (IGA) Success Rate at Week 12 | From Baseline to Week 12 | Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12. |
Countries
Canada, Germany, Hungary, Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CD5789 (Trifarotene) 50μg/g Cream CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks. | 612 |
| Placebo Cream Placebo cream applied once daily for 12 weeks | 596 |
| Total | 1,208 |
Baseline characteristics
| Characteristic | CD5789 (Trifarotene) 50μg/g Cream | Total | Placebo Cream |
|---|---|---|---|
| Age, Categorical <=18 years | 314 Participants | 592 Participants | 278 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 298 Participants | 616 Participants | 318 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 135 Participants | 283 Participants | 148 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 477 Participants | 925 Participants | 448 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Physician Global Assessment Scale Face Almost Clear | 0 Participants | 0 Participants | 0 Participants |
| Physician Global Assessment Scale Face Clear | 0 Participants | 0 Participants | 0 Participants |
| Physician Global Assessment Scale Face Mild | 0 Participants | 0 Participants | 0 Participants |
| Physician Global Assessment Scale Face Moderate | 612 Participants | 1208 Participants | 596 Participants |
| Physician Global Assessment Scale Face Severe | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 11 Participants | 16 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 23 Participants | 55 Participants | 32 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants | 96 Participants | 49 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 18 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 29 Participants | 15 Participants |
| Race (NIH/OMB) White | 508 Participants | 992 Participants | 484 Participants |
| Region of Enrollment Canada | 70 participants | 139 participants | 69 participants |
| Region of Enrollment Germany | 64 participants | 124 participants | 60 participants |
| Region of Enrollment Hungary | 44 participants | 88 participants | 44 participants |
| Region of Enrollment Puerto Rico | 27 participants | 55 participants | 28 participants |
| Region of Enrollment United States | 407 participants | 802 participants | 395 participants |
| Sex: Female, Male Female | 305 Participants | 629 Participants | 324 Participants |
| Sex: Female, Male Male | 307 Participants | 579 Participants | 272 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 612 | 0 / 596 |
| other Total, other adverse events | 177 / 612 | 74 / 596 |
| serious Total, serious adverse events | 4 / 612 | 2 / 596 |
Outcome results
Primary
Investigator Global Assessment (IGA) Success Rate at Week 12
Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.
Time frame: From Baseline to Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CD5789 (Trifarotene) 50μg/g Cream | Investigator Global Assessment (IGA) Success Rate at Week 12 | 180 Participants |
| Placebo Cream | Investigator Global Assessment (IGA) Success Rate at Week 12 | 116 Participants |